FDA grants genetic treatment fast-track status
A genetic therapy for achromatopsia has received fast track designation from the US Food and Drug Administration
The product was awarded the status as a potential treatment for achromatopsia (ACHM) caused by mutations in the CNGA3 gene.
MeiraGTx and Janssen Pharmaceuticals scientists are developing the treatment, which aims to restore cone function through a sub-retinal injection.
The FDA fast track designation is designed to speed up the development of drugs used to treat serious conditions and fill unmet need.
It enables early and frequent communication between the FDA and companies developing a treatment, with the potential for faster drug approval and patient access.
President and chief executive officer of MeiraGTx, Dr Alexandria Forbes, highlighted that ACHM is a serious and debilitating disease.
“We are very pleased to have received fast track designation for AAV-CNGA3 and that the FDA has recognised a significant need exists to quickly advance new therapies for those with ACHM. We look forward to communicating closely with the FDA as we continue the clinical advancement of AAV-CNGA3.”